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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease

This study is currently recruiting participants.
Verified by Elan Pharmaceuticals, February 2008

Sponsored by: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00574132
  Purpose

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Condition Intervention Phase
Alzheimer's Disease
Drug: Bapineuzumab
Drug: Placebo Control
Phase III

Genetics Home Reference related topics:   Alzheimer disease  

MedlinePlus related topics:   Alzheimer's Caregivers   Alzheimer's Disease  

ChemIDplus related topics:   Bapineuzumab  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:   A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:   1250
Study Start Date:   December 2007
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
A: Active Comparator Drug: Bapineuzumab
0.5 mg/kg administered over approximately 60 minutes at a constant rate. Infusions given Q 13 weeks
B: Active Comparator Drug: Bapineuzumab
1.0 mg/kg administered approximately 60 minutes at a constant rate. Infusions given Q 13 weeks
C: Active Comparator Drug: Bapineuzumab
2.0 mg/kg administered over approximately 60 minutes at a constant rate. Infusions given Q 13 weeks
D: Placebo Comparator Drug: Placebo Control
Placebo administered over approximately 60 minutes at a constant rate. Infusions given Q 13 wks.

  Eligibility
Ages Eligible for Study:   50 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574132

Contacts
Contact: Study Coordinator     1-866-446-5463    

Locations
United States, California
Pharmacology Research Institue     Recruiting
      Encino, California, United States, 91316
Pharmacology Research Institute     Recruiting
      Newport Beach, California, United States, 92660
Pharmacology Research Institute     Recruiting
      Los Alamitos, California, United States, 90720
Neuro-Therapeutics Inc.     Recruiting
      Pasadena, California, United States, 91105
San Francisco Clinical Research Center     Recruiting
      San Francisco, California, United States, 94109
United States, Florida
Brain Matters Research, Inc.     Recruiting
      Del Ray Beach, Florida, United States, 33445
Palm Beach Neurological Center/Advanced Research Consultants     Recruiting
      Palm Beach Gardens, Florida, United States, 33418
United States, Michigan
Summit Research Network, Inc. (Michigan)     Recruiting
      Okemos, Michigan, United States, 48864
United States, New Jersey
The Memory Enhancement Center of America, Inc.     Recruiting
      Long Branch, New Jersey, United States, 07740
United States, New Mexico
Albuquerque Neuroscience, Inc.     Recruiting
      Albuquerque, New Mexico, United States, 87109
United States, Oregon
Summit Research Network, Inc.     Recruiting
      Portland, Oregon, United States, 97210

Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

Responsible Party:   Elan Pharmaceuticals ( Michael Grundman )
Study ID Numbers:   ELN115727-301
First Received:   December 10, 2007
Last Updated:   February 29, 2008
ClinicalTrials.gov Identifier:   NCT00574132
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Mental Disorders
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on March 21, 2008